CDS Coalition Submits Comments on FDA’s Software Precertification Pilot Program
On September 5, 2017, the Coalition submitted comments to Docket No. FDA-2017-N-4301, “Fostering Medical Innovation: A Plan for Digital Health Devices; Software Precertification Pilot Program.” The comments recommend that FDA consider providing additional avenues for stakeholder involvement in the pilot program, for example, by preparing regular public blog posts about the program.